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"While we’re disappointed with these results, we believe this research will provide the MS community important insights into this more advanced patient population, and the benefits that natalizumab may provide in areas such as upper limb function"

CAMBRIDGE, Mass.--(BUSINESS WIRE)--The Phase 3 ASCEND study investigating natalizumab in the treatment of
secondary progressive multiple sclerosis (SPMS) did not achieve its
primary and secondary endpoints, Biogen
(NASDAQ: BIIB) reported today. During the study, natalizumab was
generally well tolerated and adverse events were consistent with its
known safety profile.

ASCEND evaluated the efficacy and safety of natalizumab to slow the
accumulation of disability progression unrelated to relapse in SPMS
patients, an unmet medical need. The majority of study participants had
EDSS scores of 6.0 to 6.5 (walking aid required) and were non-relapsing
for two years prior to enrollment in the study. The study’s composite
primary endpoint evaluated the percentage of patients whose disability
had progressed on one or more of three disability measurements
comprising the composite endpoint.

Natalizumab demonstrated a statistically significant effect on upper
limb function (one of the three components of the primary composite
endpoint) unrelated to relapses. Consistent with the established effects
of natalizumab in relapsing multiple sclerosis, analyses of exploratory
endpoints suggest that some patients received a benefit from treatment,
including reduction of relapses and new MRI lesions.

“While we’re disappointed with these results, we believe this research
will provide the MS community important insights into this more advanced
patient population, and the benefits that natalizumab may provide in
areas such as upper limb function,” said Alfred Sandrock, M.D., Ph.D.,
group senior vice president and chief medical officer at Biogen. “Given
the challenges of treating this advanced stage of MS, these results
underscore the importance of treatment early in the course of disease
with effective disease-modifying therapies before a patient advances to
SPMS.”

SPMS is characterized by ongoing nerve damage or loss and patients
experience disability progression with increasingly less frequent
relapses. Despite extensive clinical research, treatment options for
patients with SPMS are extremely limited and none have demonstrated
efficacy in slowing the progression of disability unrelated to relapse.

Natalizumab is a high-efficacy treatment for patients with relapsing
forms of MS, including relapsing-remitting MS. The safety and efficacy
of natalizumab has been established across a robust clinical program and
real-world use with more than a decade of clinical experience
demonstrating its benefits on disease progression and sustained efficacy
in relapsing MS with a well-characterized safety profile.

Detailed results from ASCEND will be presented at a future medical
conference.

About ASCEND

ASCEND (A Study to Characterize the Efficacy of Natalizumab
on Disability in SPMS) was a randomized, double-blind,
placebo-controlled, Phase 3 trial involving 889 patients in 15
countries. Participants were randomized to receive either natalizumab
300 mg or placebo intravenously every four weeks for 96 weeks.

The primary endpoint of the study was the percentage of patients with
confirmed progression of disability on one or more components of
ASCEND’s composite endpoint: the Expanded Disability Status Scale
(EDSS), Timed 25-Foot Walk (T25FW) and the 9-Hole Peg Test (9HPT) where
progression was confirmed at a second visit at least 6 months later and
at week 96.

About TYSABRI® (natalizumab)

TYSABRI is a DMT approved in more than 65 countries. In the United
States, TYSABRI is indicated as monotherapy for the treatment of
patients with relapsing forms of MS. In the European Union, it is
indicated as a single DMT in highly active relapsing-remitting MS for
adult patients who have high disease activity despite treatment with a
beta interferon or glatiramer acetate or patients with rapidly evolving
severe RRMS.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy
(PML), an opportunistic viral infection of the brain which usually leads
to death or severe disability. Risk factors that increase the risk of
PML are presence of anti-JCV antibodies, prior immunosuppressant use,
and longer TYSABRI treatment duration. Patients who have all three risk
factors have the highest risk of developing PML. TYSABRI increases the
risk of developing encephalitis and meningitis caused by herpes simplex
and varicella zoster viruses. Serious, life-threatening, and sometimes
fatal cases have been reported in the postmarketing setting in multiple
sclerosis patients receiving TYSABRI. Clinically significant liver
injury has also been reported in the post-marketing setting.

Other serious adverse events that have occurred in TYSABRI-treated
patients include hypersensitivity reactions (e.g., anaphylaxis) and
infections, including opportunistic and other atypical infections.

TYSABRI has advanced the treatment of MS patients with its proven
ability to slow the progression of disability, reduce relapse rates, and
impact the number of MRI brain lesions with a well-characterized safety
profile. Data from the Phase 3 AFFIRM trial, which was published in the New
England Journal of Medicine, showed that at two years, TYSABRI
treatment led to a 67 percent relative reduction (p<0.001) in the
annualized relapse rate when compared with placebo and reduced the
relative risk of disability progression by 42 percent (p<0.001).

TYSABRI is a monoclonal antibody that selectively binds to α4-integrin
and is thought to interrupt the activity of inflammatory cells in MS
patients by blocking the interaction between α4β1-integrin and vascular
cell adhesion molecule-1. Disruption of these molecular interactions
prevents transmigration of leukocytes across the endothelium into
inflamed parenchymal tissue. The specific mechanism(s) by which TYSABRI
exerts its effects in multiple sclerosis have not been fully defined.

For additional important safety information, and the United States full
prescribing information, please visit www.TYSABRI.com
or your respective country’s website.

About Biogen

Through cutting-edge science and medicine, Biogen discovers, develops
and delivers to patients worldwide innovative therapies for the
treatment of neurodegenerative diseases, hematologic conditions and
autoimmune disorders. Founded in 1978, Biogen is one of the world’s
oldest independent biotechnology companies and patients worldwide
benefit from its leading multiple sclerosis and innovative hemophilia
therapies. For product labeling, press releases and additional
information about the company, please visit www.biogen.com.

Safe Harbor

This press release contains forward-looking statements, including
statements about potential insights into treatments for SPMS. These
statements may be identified by words such as "believe," "expect,"
"may," "plan," "potential," "will" and similar expressions, and are
based on the company’s current beliefs and expectations. Drug
development involves a high degree of risk, and only a small number of
research and development programs results in the commercialization of a
product or additional product indications. Success in preclinical work
or early stage clinical trials does not ensure that later stage or
larger scale clinical trials will be successful. For more detailed
information on the risks and uncertainties associated with Biogen's drug
development activities, please review the Risk Factors section of
Biogen's most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and the company assumes no
obligation to update any forward-looking statements, whether as a result
of new information, future events or otherwise.